STOCKHOLM, Jan. 10, 2019 /PRNewswire/ --
IRRAS AB (Nasdaq First North Premier: IRRAS), a
commercial-stage medical-technology company, today announced
that the first patient in the United States was
successfully treated with IRRAflow, the company's
initial product that offers an innovative, therapeutic
approach to the fluid management of patients with intracranial
bleeding.
"The US is the largest market for intracranial procedures, and
we are making significant progress engaging
neurocritical care centers and specialty hospitals across the
country," said Kleanthis G.
Xanthopoulos, Ph.D., President and CEO of IRRAS. "We're
thrilled to see the first patient treated in the United
States and remain confident that
IRRAflow will dramatically improve the outcomes for
many future patients."
This first IRRAflow patient treatment in the US was
performed at the University of
California – Irvine (UCI)
Medical Center, located in Orange,
California. The team, led by UCI Health neurosurgeon Dr.
Sumeet Vadera, successfully treated
a patient suffering from a chronic subdural hematoma that formed
after a recent fall.
"We are excited to be the first site in the United States to use the IRRAflow
system," said Dr. Vadera, Associate Professor of Neurological
Surgery, UCI School of Medicine. "At UCI, we pride ourselves on
providing our patients the latest in cutting-edge treatment
options, and we can now provide the first active, therapeutic
treatment to manage intracranial fluid with IRRAflow."
IRRAflow addresses the complications associated with
current passive treatment methods by using a dual lumen
catheter that combines active irrigation with ongoing fluid
drainage. Since receiving US Food and Drug Administration (FDA)
clearance in 2018 to market the system in the United States, IRRAS has taken many
needed steps to launch the product, including establishing a
customer service and shipping partnership with global logistics
specialist, HealthLink Europe & International, hiring
Territory Managers, and developing needed marketing and training
materials.
This document is considered information that IRRAS is obliged
to disclose pursuant to the EU Market Abuse Regulation. The
information was released for public disclosure, through the agency
of the contact person below on January 10, 2019
at 08.00 a.m. (CET).
For more information, please contact:
US
Kleanthis G.
Xanthopoulos, Ph.D.
President & CEO
info@irras.com
Europe
Fredrik Alpsten
CFO and Deputy CEO
+46-706-67-31-06
fredrik.alpsten@irras.com
About IRRAS
IRRAS AB (Nasdaq First North Premier: IRRAS) is a
publicly-traded, commercial-stage medical technology company
focused on developing and commercializing innovative solutions for
brain surgery. The company's initial product,
IRRAflow®, addresses the complications associated with
the current methods of managing intracranial fluid by using a dual
lumen catheter that combines active irrigation with ongoing fluid
drainage. IRRAflow received FDA clearance in
July 2018.
Regularly during treatment, the IRRAflow catheter is
automatically flushed to prevent common catheter occlusions from
forming. Because IRRAflow is a completely closed
system, it is designed to reduce the documented
infection risk of these procedures. Additionally,
IRRAflow incorporates ICP monitoring and uses a
proprietary software to regulate treatment based on desired
pressure levels.
With its unique product portfolio, protected by property patents
and patent applications, IRRAS is well positioned to establish a
leadership position in the medical device market. IRRAS maintains
its headquarters in Stockholm,
Sweden, with corporate offices in Munich, Germany, and San Diego, California, USA. For more
information, please visit www.irras.com.
IRRAS AB (publ) is listed on Nasdaq First North Premier. Wildeco
is certified adviser of the company. Wildeco is reached at +
46-706-67-31-06 or at info@wildeco.se.
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SOURCE IRRAS